Tag Archives: CVM

FDA Announces Upcoming Efforts to Combat Antimicrobial Resistance in Animals

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In a July 31, 2018 press release, FDA Commissioner Scott Gottlieb announced upcoming efforts by FDA to implement “good antimicrobial stewardship practices.”  FDA’s Center for Veterinary Medicine (CVM) has already taken steps to support judicious use in animals of antimicrobials important for treating human disease. FDA will soon publish a five-year blueprint to further address … Continue Reading

FDA Releases Guidance on Evaluating Animal Drug Safety in Food-Producing Animals

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FDA’s Center for Veterinary Medicine (CVM) has released a new guidance document (Guidance for Industry #3:  General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals) describing the types of information that the Center expect to see when such drugs are used in food-producing animals. Under Section 512(b)(1) of … Continue Reading

FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

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The second major compliance dates are coming up for the Preventive Controls for Animal Food Rule under FDA’s Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016. As … Continue Reading

Chicken Out

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FDA approves transgenic chicken, but not for consumption. FDA has the authority to approve genetically modified (GM) animals as “new animal drugs.”  In 2009, FDA approved a GM goat — the ATryn Goat — that produces a therapeutic biologic in its milk.  In November 2015, FDA approved its first-ever GM animal intended for direct human consumption — the … Continue Reading

Cold Turkey

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FDA announces pending withdrawal of arsenic-based drug approved for use in food animals. FDA regulates the use of animal drugs used in companion animals and food-producing animals. FDA has announced its receipt of a letter of commitment from the manufacturer of the last arsenic-based animal drug currently approved for use in food animals, namely poultry.  Although … Continue Reading

Pet Peeves

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Senators criticize FDA for inadequate pet protections. FDA oversees the safety of animal feed and pet food in the U.S.  Due to some idiosyncrasies in the animal food regulatory framework, FDA shares its pet food oversight responsibilities with state regulatory officials and the Association of American Feed Control Officials (AAFCO).  FDA has been tasked with … Continue Reading

MOUr FDA-AAFCO Collaboration

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FDA and AAFCO extend MOU regarding animal food ingredient definitions. Since 2007, FDA and the Association of American Feed Control Officials (AAFCO) have worked together under a memorandum of understanding (MOU) to review and sanction the use of various animal food ingredients.  Currently, animal food ingredients may be marketed on the basis of a formal … Continue Reading

Animal Feed Activity

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FDA to create definitions and standards for animal food ingredients. For years, animal feed and pet food ingredients have been marketed in the U.S. with the blessing of FDA and/or the Association of American Feed Control Officials (AAFCO) (a voluntary membership organization including both federal and state regulatory officials).  Currently, the lawful marketing of an … Continue Reading
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